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[2011] Good Practice Guide：Cold Chain Management 英文名：Good Practice Guide：Cold Chain Management 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2011 版本：1st Edition 页码：140页 ISBN：978-1-936379-07-1 解压密码：egeeker.com	admin 2021-3-2	11401	eltonelce 2023-4-19 10:11
[2017] GAMP Good Practice Guide：IT Infrastructure Control and Compliance 2nd Edition 英文名：GAMP Good Practice Guide：IT Infrastructure Control and Compliance 2nd Edition 2017 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2017 版本：2nd Edition 页码：168页 ISBN：978-1-936379-92-7 解压密码：** 本内容需购买 **	admin 2021-3-1	11452	eltonelce 2023-4-19 10:05
[2022] GAMP 5 Guide：Compliant GxP Computerized Systems 2nd Edition 英文名：GAMP 5 Guide：Compliant GxP Computerized Systems 2nd Edition 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2022 版本：2nd Edition 页码：404页 ISBN：978-1-946964-57-1 ** 本内容需购买 **	admin 2023-4-6	0214	admin 2023-4-6 17:59
[2021] GAMP Good Practice Guide：Enabling Innovation. Critical Thinking, Agile, IT Service Management 英文名：GAMP Good Practice Guide：Enabling Innovation. Critical Thinking, Agile, IT Service Management 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2021 版本：1st Edition 页码：102页 ISBN：978-1-946964-46-5 ** 本内容需购买 **	admin 2023-4-6	0215	admin 2023-4-6 17:52
[2020] Guide：Cleaning Validation Lifecycle. Applications, Methods and Controls 英文名：Guide：Cleaning Validation Lifecycle. Applications, Methods and Controls 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2020 版本：1st Edition 页码：236页 ISBN：978-1-946964-31-1 ** 本内容需购买 **	admin 2023-4-6	0182	admin 2023-4-6 17:42
[2018] Good Practice Guide：Single-Use Technology 英文名：Good Practice Guide：Single-Use Technology 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2018 版本：1st Edition 页码：180页 ISBN：978-1-946964-13-7 ** 本内容需购买 **	admin 2023-4-6	0187	admin 2023-4-6 17:23
[2022] Good Practice Guide：Continuous Manufacturing of Oral Solid Dosage Forms 英文名：Good Practice Guide：Continuous Manufacturing of Oral Solid Dosage Forms 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2022 版本：1st Edition 页码：142页 ISBN：978-1-946964-54-0 ** 本内容需购买 **	admin 2023-4-6	0207	admin 2023-4-6 17:12
[2010] GAMP Good Practice Guide：Manufacturing Execution Systems - A Strategic and Program Management Approach 英文名：GAMP Good Practice Guide：Manufacturing Execution Systems - A Strategic and Program Management Approach 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2010 版本：1st Edition 页码：144页 ISBN：1-931879-93-1 解压密码：** 本内容需购买 **	admin 2020-8-2	21936	jason6174 2022-9-9 11:37
[2008] Good Practice Guide：Good Engineering Practice 英文名：Good Practice Guide：Good Engineering Practice 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2008 版本：1st Edition 页码：196页 ISBN：978-1-931879-54-0 解压密码：** 本内容需购买 **	admin 2021-3-2	11414	admin 2022-2-11 14:33
[2016] Good Practice Guide：Controlled Temperature Chamber Mapping and Monitoring 英文名：Good Practice Guide：Controlled Temperature Chamber Mapping and Monitoring 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2016 版本：1st Edition 页码：116 页 ISBN：978-1-936379-86-6 解压密码：egeeker.com	admin 2021-8-28	11749	admin 2022-2-11 14:31
[2021] Good Practice Guide：Controlled Temperature Chambers, Commissioning and Qualification, Mapping and Monitoring 2nd Edition 英文名：Good Practice Guide：Controlled Temperature Chambers, Commissioning and Qualification, Mapping and Monitoring 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2021 版本：2nd Edition 页码：134 页 ISBN：978-1-946964-51-9 The primary purpose of this revision was to align with the ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition). Revising the Guide provided the opportunity to consider a periodic review frequency based on risk of failure to maintain uniform temperature and criticality of product stored rather than a standard, one-size-fits-all time span. In addition, the Guide was expanded to include ultra-low freezers, decommissioning a unit, and a discussion on using ocean reefers. 解压密码 ** 本内容需购买 **	admin 2022-2-11	02524	admin 2022-2-11 14:27
[2021] Good Practice Guide：Good Engineering Practice 2nd Edition 英文名：Good Practice Guide：Good Engineering Practice 2nd Edition 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2021 版本：2nd Edition 页码：244 页 ISBN：978-1-946964-48-9 This ISPE Good Practice Guide aims to provide a definition and explanation of the term Good Engineering Practice (GEP). It describes the fundamental elements of GEP as it should exist in the pharmaceutical industry, encompassing core concepts and engineering practices. The concepts and practices of GEP are fundamental and applicable, to varying degree, to other regulated industries. 解压密码：** 本内容需购买 **	admin 2022-2-11	01485	admin 2022-2-11 14:06
[2019] Good Practice Guide：Practical Implementation of the Lifecycle Approach to Process Validation 英文名：Good Practice Guide：Practical Implementation of the Lifecycle Approach to Process Validation 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2019 版本：1st Edition 页码：208 页 ISBN：978-1-946964-18-2 解压密码：ISPE20210828	admin 2021-8-28	01447	admin 2021-8-28 10:03
[2014] Good Practice Guide：Clinical Supply Systems 英文名：Good Practice Guide：Clinical Supply Systems 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2014 版本：1st Edition 页码：118 页 ISBN：978-1-936379-68-2 解压密码：** 本内容需购买 **	admin 2021-8-21	01082	admin 2021-8-21 23:02
[2012] Good Practice Guide：Comparator Management 英文名：Good Practice Guide：Comparator Management 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2012 版本：1st Edition 页码：84 页 ISBN：978-1-936379-33-0 解压密码：egeeker.com	admin 2021-8-21	01726	admin 2021-8-21 22:35
[2017] Good Practice Guide：Decommissioning Pharmaceutical Equipment and Facilities 英文名：Good Practice Guide：Decommissioning Pharmaceutical Equipment and Facilities 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2017 版本：1st Edition 页码：132 页 ISBN：978-1-936379-99-6	admin 2021-8-21	01568	admin 2021-8-21 18:54
[2007] Good Practice Guide：Development of Investigational Therapeutic Biological Products 英文名：Good Practice Guide：Development of Investigational Therapeutic Biological Products 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2007 版本：1st Edition 页码：90 页 ISBN：1-931879-91-5 解压密码：egeeker.com	admin 2021-8-21	02982	admin 2021-8-21 18:33
[2013] Good Practice Guide：Harmonizing the Definition and Use of Non-Investigational Medicinal Products（NIMPs）英文名：Good Practice Guide：Harmonizing the Definition and Use of Non-Investigational Medicinal Products（NIMPs）出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2013 版本：1st Edition 页码：56 页 ISBN：978-1-936379-57-6 解压密码：** 本内容需购买 **	admin 2021-8-21	01182	admin 2021-8-21 14:47
[2011] Good Practice Guide：Interactive Response Technology 英文名：Good Practice Guide：Interactive Response Technology 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2011 版本：1st Edition 页码：93 页 ISBN：978-1-936379-27-9 解压密码：egeeker.com	admin 2021-8-21	0908	admin 2021-8-21 14:41
[2021] Good Practice Guide：Maintenance 2nd Edition 英文名：Good Practice Guide：Maintenance 2nd Edition 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2021 版本：2nd Edition 页码：132 页 ISBN：978-1-946964-38-0 解压密码：M20210821	admin 2021-8-21	01697	admin 2021-8-21 14:28
[2016] Good Practice Guide：Management of Engineering Standards 英文名：Good Practice Guide：Management of Engineering Standards 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2016 版本：1st Edition 页码：52 页 ISBN：978-1-936379-85-9 解压密码：EGEEKER.COM	admin 2021-8-21	01339	admin 2021-8-21 14:22
[2012] Good Practice Guide：Ozone Sanitization of Pharma Water Systems 英文名：Good Practice Guide：Ozone Sanitization of Pharma Water Systems 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2012 版本：1st Edition 页码：144 页 ISBN：978-1-936379-45-3 解压密码：EGEEKER.COM	admin 2021-8-21	0746	admin 2021-8-21 14:13
[2021] Good Practice Guide：Knowledge Management in the Pharmaceutical Industry 英文名：Good Practice Guide：Knowledge Management in the Pharmaceutical Industry 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2021 版本：1st Edition 页码：160页 ISBN：978-1-946964-42-7 解压密码：** 本内容需购买 **	admin 2021-8-21	02775	admin 2021-8-21 14:05
[2017] GAMP Good Practice Guide：Validation and Compliance of Computerized GCP Systems and Data 英文名：GAMP Good Practice Guide：Validation and Compliance of Computerized GCP Systems and Data 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2017 版本：2nd Edition 页码：128页 ISBN：9781946964038 解压密码：** 本内容需购买 **	admin 2021-3-1	11163	Phusi 2021-3-15 21:39
[2020] APQ Guide：Corrective Action and Preventive Action (CAPA) System 英文名：APQ Guide：Corrective Action and Preventive Action (CAPA) System 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2020 版本：1st Edition 页码：136页 ISBN：978-1-946964-36-6 解压密码：** 本内容需购买 **	admin 2021-3-3	02703	admin 2021-3-3 09:03
[2020] Good Practice Guide：Equipment Reliability 英文名：Good Practice Guide：Equipment Reliability 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2020 版本：1st Edition 页码：140页 ISBN：978-1-946964-37-3 解压密码：** 本内容需购买 **	admin 2021-3-3	01667	admin 2021-3-3 08:55
[2012] PQLI Guide：Part 4 - Process Performance and Product Quality Monitoring System 英文名：PQLI Guide：Part 4 - Process Performance and Product Quality Monitoring System 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2012 版本：1st Edition 页码：81页 ISBN：978-1-936379-60-6 解压密码：** 本内容需购买 **	admin 2021-3-2	01630	admin 2021-3-2 21:42
[2012] PQLI Guide：Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System 英文名：PQLI Guide：Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2012 版本：1st Edition 页码：56页 ISBN：978-1-936379-46-0 解压密码：** 本内容需购买 **	admin 2021-3-2	03196	admin 2021-3-2 21:39
[2011] PQLI Guide：Part 2 - Product Realization using QbD - Illustrative Example 英文名：PQLI Guide：Part 2 - Product Realization using QbD - Illustrative Example 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2011 版本：1st Edition 页码：233页 ISBN：978-1-936379-23-1 解压密码：** 本内容需购买 **	admin 2021-3-2	02955	admin 2021-3-2 21:32
[2011] PQLI Guide：Part 1 - Product Realization using QbD - Concepts and Principles 英文名：PQLI Guide：Part 1 - Product Realization using QbD - Concepts and Principles 出版社：International Society for Pharmaceutical Engineering (ISPE) 年份：2011 版本：1st Edition 页码：188页 ISBN：978-1-936379-22-4 解压密码：** 本内容需购买 **	admin 2021-3-2	02334	admin 2021-3-2 21:26

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法规事务今日: 0|主题: 49|排名: 3